BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

    K Number: K871680 · Decision Jun 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    296
    Review Days
    40

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    Basic Information

    Device Name
    MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
    K Number
    K871680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    April 29, 1987
    Decision Date
    June 8, 1987
    Product Code
    LAN
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LAN Enzyme Immunoassay, N-Acetylprocainamide

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